NCT01945931

Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia

Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia: A Cluster-randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,601 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: Female
• Age: 10 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine if the safe delivery smartphone application distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage. It is also the purpose to determine if the safe delivery smartphone application distributed to health workers in Ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation.

Detailed description

Abstract Hypothesis A safe delivery smartphone application distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage A safe delivery smartphone application distributed to health workers in Ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation Intervention A safe delivery smartphone application with animated videos to improve clinical management during delivery will be introduced in the intervention clusters Design Cluster randomized controlled trial with health facilities as the unit of randomization Area Nole Kaba, Haru, Homa, Genji and Gimbie districts in Ethiopia Population Pregnant women and their newborns delivered in a randomized health facility. For secondary outcomes health workers at randomized health facilities. Sample size 77 health facilities with minimum 2 health workers per facility and 30 deliveries per health worker Duration Pregnant women will be enrolled at delivery and followed to 7 days postpartum Outcomes Primary outcomes are perinatal mortality and postpartum haemorrhage. Secondary outcomes are health workers knowledge and skills Study time Data collection expected from September 2013 to September 2014

Conditions

• Maternal Mortality
• Perinatal Mortality

Interventions

Type	Name	Description
OTHER	Safe Delivery Smartphone Application	The safe delivery smartphone application is designed to train midwives and other birth attendants in developing countries in management of normal and complicated deliveries. The application is furthermore intended as a reference tool that could be used during clinical work for example for preparation before attending a birth, in a situation when a complication occurs, or for debriefing and self-evaluation after a complication. The application features four animated videos with clinical instructions of 3-8 minutes duration and written lists of essential obstetric drugs (indications, contraindications, dosage and administration and side effects) and essential equipment for a safe delivery.

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2013-09-19
• Last updated: 2015-10-08

Locations

1 site across 1 country: Denmark